Medical Device Senior Validation Engineers
Status: Contractor position: Full-time/Temporary
Assignment duration: TBD
Targeted start date: TBD
Location: Various Locations
Travel: Daily commute or relocation to the client job location is required for the duration of the assignment.
Report to: Project Manager
Description:
Conducts validation activities for more complicated integrated systems and stand alone processes by generating and/or approving validation related documents, executing validation protocols, and summarizing test results. Sr.VE has supervisory experience and is able to coordinate/manage multiple validation efforts/validation team members. In many cases, Sr. VE will be the subject matter experts in a specific discipline to ensure appropriate validation requirements and standards have been met; minimum 8 years experience.
Responsibilities:
- · Strong project management skills and experience managing teams of engineers.
- · Good multi tasking and problem solving skills
- · Ability to affectively coach others
- · Ability to affectively interact with management from all levels
- · Proficient in developing and writing FDS, RTM, IQ, OQ, and PQ
- · Ability to coordinate and execute validation activities
- · Strong understanding of process validation methodology
- · Good technical writing skills
- · Ability to communicate with client management as well as engineer and hourly staff
- · Strong pharmaceutical manufacturing background (especially aseptic processing)
- · Basic knowledge and understanding of QSR, GDP’s and GMP’s
- · Understanding of test method validation and statistical tools
- · Prefer experience in facility and utility qualifications
- · Experience with risk analysis
Requirements
- BS or MS education, preferably with an Engineering background
- Minimum 8 years experience
- Knowledge of the Medical industry sectors and a background in FDA compliance is required
